Virtual reality
DeviceThe VR system will be worn for approximately 5-10 minutes during dental sealant application
NCT Number: NCT05585905
Dental Fear and Anxiety is an emotional experiences affecting many children and adolescents which can lead to behavioral problems in the dental setting. The purpose of the proposed study is to investigate the effect of virtual reality on anxiety, behavior, and pain in children undergoing restorative dental procedures. Children enrolled in the study will include patients ages 6-18 who are healthy and require two or more dental sealants (at least one sealant per side). The participants in the study will serve as their own control using a split-mouth cross-over randomized control clinical trial design and will be randomly assigned to receive virtual reality or traditional behavior guidance techniques first during dental sealant placement. The objectives of this study are to explore the associations between the use of virtual reality distraction during dental sealant placement with anxiety based on the change in heart rate, compared with to the control group. This model will include treatment, visit, treatment by visit interaction term as well as a treatment sequence variable. This is a pilot study. Data analyzed will be changed in heart rate between baseline and sealant placement using virtual reality or behavior guidance technique.. No statistical analysis will be conducted except mean and range.
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Notify Me6 year–18 year
All sexes
Interventional
Not applicable
Children's Dental Health Clinic, Long Beach, California, United States
This study is a randomized controlled trial with a crossover design. Patients who are visiting the clinic for a comprehensive or periodic dental exam and are found to require two or more dental sealants (at least one sealant per side). The study subjects will include children ages 6-18 who are ASA I or II, as defined by the American Society of Anesthesiologists classification system. The proposed sample size for the study is 40 participants.
The children who are enrolled in the study will serve as both the experimental group and their own control. This is a split mouth design in which children who are enrolled in the study will serve as both the experimental group and their own control. After the child and parent are scheduled for the dental sealant appointment, they will be randomly assigned to receive the virtual reality system as a distraction technique for the first half or the latter half of the appointment (for research purposes). During the time when virtual reality is not used, traditional basic behavior guidance techniques will be used, as is the standard of care.
The virtual reality system being used for research purposes is the RelieVR by Applied VR which includes the goggle headset only. The VR experience will be an immersive experience where the child will interact with the system and navigate their way through a game that will involve bright colors, cartoon-like characters and settings with age-appropriate content. The VR system will be worn for approximately 5-10 minutes during the dental sealant application.
The behavior, and anxiety will be analyzed at specific steps of the procedure including:
The patient's anxiety will be evaluated with a change in heart rate.
Additionally, at the end of each appointment for the duration of the study, the provider will assign the patient a Frankl behavior score 1-5, and record it in the patient's chart, as is the standard of care. The provider will also complete a Healthcare Provider Questionnaire through Qualtrics.
The demographic factors will be collected from the patient's medical chart. The parent will be asked "how many hours of "screen time" (TV, computer, video games, tablet use), would you say that your child is allowed per week?". Parents and patients will also be asked to complete a satisfaction survey post-treatment.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
The VR system will be worn for approximately 5-10 minutes during dental sealant application
Basic behavior guidance techniques will be used as a distraction technique when the VR system is not used during the dental sealant application
Time frame: Time from is from baseline until sealant placement with VR
Behavior and anxiety measured by changed in heart rate were scored at baseline and during sealant placement with virtual reality
Time frame: Time from is from baseline until sealant placement with BBG
Behavior and anxiety measured by changed in heart rate were scored at baseline and during sealant placement with basic behavior guidance.
University of Southern California
Other
The Effect of Virtual Reality on the Behavior of Pediatric Dental Patients During Dental Sealant Application.
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